The story of the Expert Committee that recommended Bt Brinjal for commercial cultivation in India
Submission by Kavitha Kuruganti
On October 14th 2009, the apex regulatory body for GMOs (Genetically Modified Organisms) in India - the Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment & Forests (MoEF), gave a go-ahead for the commercial release of Bt Brinjal, the first ever such Genetically Modified (GM) food crop anywhere in the world with the toxin-producing Bt gene in it.
The GEAC based its decision, with some dissenting voices recorded, on the recommendations of an Expert Committee (referred to hereafter as EC2, specifically referring to this expert committee on Bt Brinjal, as opposed to EC1, another Expert Committee constituted in 2006-07).
EXPERT COMMITTEE 2 ON BT BRINJAL
When independent reviews of Mahyco’s biosafety data started coming in, in the month of January 2009 (after the data was put up on the Indian regulators’ official website in October 2008 after a protracted Right To Information struggle and after the Supreme Court passed orders to this effect), the GEAC in its meeting on 14th January 2009, decided to set up an Expert Committee (a Sub-Committee, as it was called at that time). The decision in this 91st meeting of the GEAC was recorded as under:
“5.1.4 After detailed deliberations, the Committee decided to set up a Sub-committee comprising of representatives from the Ministry of Health and Family Welfare, NIN, ICMR, CFTRI, CCMB, IIVR, NDRI, CFIE, MoEF, DBT, TNAU and UAS Dharwad with the following terms of reference:
- to review the adequacy of the biosafety data on Bt brinjal
- to review the adequacy of the toxicity and allergenicity protocols
- to suggest further studies, if any, based on the review of the international practices in biosafety assessment and representations received by the GEAC
- based on such reviews make suitable recommendations for consideration of the GEAC”.
On February 10th and 11th 2009, many faxes were sent from civil society groups across the country asking GEAC to review the mandate for the Sub-Committee and to remove conflicting interests in the committee.
As per an Office Memorandum dated 29/5/2009, the GEAC constituted an Expert Committee consisting of 16 members, headed by Prof Arjula R Reddy, Vice Chancellor of Yogi Vemana University, Hyderabad and currently also the Co-Chair of GEAC.
Interestingly enough, the Terms of Reference for this Committee were:
*to review the findings of the data generated during the large scale trials ;
*to review the biosafety data of Bt brinjal in light of the available scientific evidence, reports from international/national experts and representations from NGOs and other stakeholders;
*to make appropriate recommendations for consideration of the GEAC based on the above review.
One could argue that this new ToR itself is a departure from the decision taken in the January meeting of the GEAC, with regard to the rationale for the constitution of the committee. Further, it has to be noted that the large scale trials’ findings along with findings from pollen flow, soil impacts and crossability studies were put in the public domain only on November 16th 2009, a full month after the Expert Committee came up with its recommendation and this did not go through any independent analysis or review.
On and around the 30th of July, soon after the office memorandum was put up in the public domain, civil society groups once again wrote to the GEAC pointing out to the need to change the mandate of the Expert Committee as well as the inclusion of conflicting interests in the constitution of the Expert Committee (Annexure 1). In addition, on 2nd September and on 11th October 2009, in email communications sent to the Hon’ble Minister for Environment & Forests, these issues have been raised with him too, to update him and seek his intervention.
It has to be noted here that an earlier Expert Committee (EC1) set up in 2006 also presented similar issues for the country, when a GM crop developer was asked to head that Committee. It was only in the second meeting of this EC1 that the GM crop developer was replaced by another scientist.
“EC 2 DESIGNED TO APPROVE BT BRINJAL”
The EC2 had 16 members including the following:
1. Prof. Arjula R. Reddy, Vice Chancellor, Yogi Vemana University, Hyderabad and Co-chairman, GEAC (Chairperson of the EC2).
2. Dr Vasantha Muthuswamy, Former Chief (BMS), ICMR, New Delhi: Member
3. Dr. B. Sesikaran, Director, National Institute of Nutrition, Hyderabad: Member
4. Dr. Lalitha R. Gowda, Scientist, CFTRI, Mysore: Member
5. Dr. N. Madhusudan Rao, Deputy Director, CCMB, Hyderabad: Member
6. Dr. C. M. Gupta, Former Director, Central Drug Research Institute, Lucknow: Member
7. Dr S. B. Dongre, Director (F&VP), Food Safety and Standards Authority (FSSA), New Delhi - (Representative of MoH&FW): Member
8. Dr. Dhir Singh, ADG (PFA), FSSAI - (Representative of MoH&FW): Member
9. Dr. K. Satyanarayan, Scientist G, ICMR, New Delhi: Member
10. Dr. Dharmeshwar Das, Director, Indian Veterinary Research Institute, Izatnagar: Member
11. Dr. A. K. Srivastava, Director, National Diary Research Institute, Karnal: Member
12. Dr. Dilip Kumar, Director, Central Institute of Fisheries Education, Mumbai: Member
13. Dr. Mathura Rai, Director, Indian Institute of Vegetable Research, Varanasi: Member
14. Dr. P. Anand Kumar, Project Director, NRCPB, IARI, New Delhi: Member
15. Dr. K. K. Tripathi, Adviser, DBT, New Delhi: Member
16. Dr R Warrier, Director and MS GEAC: Convener
A re-look at the EC2
1. Prof Arjula Reddy, the Chair of the Committee:
In a phone conversation to Dr Pushpa Bhargava, Prof Reddy is supposed to have told Dr Bhargava, sometime in the first week of October (?):
”¢ that eight of the tests that Dr Bhargava said should be done on Bt Brinjal and with which Prof Reddy agreed, had not been done;
”¢ that even in the case of tests that have been done, many have not been done satisfactorily and adequately;
”¢ that he (Prof Reddy) was under ‘tremendous pressure’ to clear Bt Brinjal and had calls from ‘Agriculture Minister, GEAC and industry’.
Attached is a note/affidavit from Dr Bhargava on this matter (Annexure 2). Prof Reddy has also been quoted in a Tehelka article on Bt Brinjal recently in the following manner:
When asked if there was any proof Bt brinjal was safe, he replied, “What we require is longrange research done over many years. That does not exist (for Bt brinjal).” Then why give the clearance if the required research is absent? “All the approved protocols by the government has been fulfilled by the developers and the public institutions [that participated in the safety assessment].”
Source: Uber Gene, Tehelka Magazine, Vol 6, Issue 44, Dated November 07, 2009 at http://www.tehelka.com/story_main43.asp?filename=Ne071109uber_gene.asp
However, these views are not reflected in the final report of the EC2, indicating that Prof Reddy succumbed to pressure.
2. Dr K K Tripathi, Review Committee on Genetic Manipulation, Dept of Biotechnology
A complaint is pending against Dr K K Tripathi with the Central Vigilance Commission (CVC) (complaint dated 6/6/09 from Nuziveedu Seeds, and Central Vigilance Commission Complaint No. 780/09/6, being examined in the Commission Annexure 3), for “abuse of power”. This complaint, filed by Nuziveedu Seeds Ltd, points out that Dr Tripathi has been exercising undue discretionary powers to promote interests of certain companies of his choice (Mahyco specifically) and harm others. The CVC complaint lodged points out the following:
“The RCGM, MEC and GEAC are independent committees meant to act as checks and balance for each other and prevent any one individual from influencing their decision. However, the presence of one person (Dr. K K Tripathi) on all three committees and in the capacity of Member Secretary on two key committees besides his administrative powers as Advisor DBT, has given him a chance to manipulate the decisions in these committees to further his vested agenda by misinforming and misrepresenting facts in these committees”.
Dr Tripathi was also part of the EC2! It violates any principle of fair inquiry to have him in this committee when investigations are pending against a complaint for his excessive favouring of Mahyco when the EC2 was considering a Mahyco application for Bt Brinjal commercialization!
Further, Dr Tripathi was the one who signed off on various protocols and permission letters for testing Bt Brinjal’s biosafety and efficacy and obviously thought this was adequate and appropriate, while the Expert Committee was supposed to be reviewing the concerns expressed on these very protocols and studies!
3. Dr Mathura Rai, Director, Indian Institute of Vegetable Research (IIVR)
He/IIVR is part of the ABSP II project (more details in Annexure 4). This project is funded by USAID, which in turn gets funded by Monsanto for certain projects and funds Monsanto for certain other projects. ABSPII is “supporting Mahyco in gaining regulatory approval for the technology””¦ says a project document on the official website (http://www.absp2.cornell.edu).
USAID funding of this project goes expressly into activities like: “Support Mahyco’s efforts to complete regulatory approval”!
Dr Mathura Rai also acted as the lead investigator, so to speak, on the large scale trials of Mahyco’s Bt Brinjal in the past two years. He directly supervised all the trials as recommended by the Expert Committee (EC1 led by Dr Deepak Penthal/Dr C R Babu) and generated findings.
He not only did these studies even though he is part of ABSPII but he also reviewed his own findings by being part of the Expert Committee set up “to review findings from large scale trials and other biosafety tests”! Incidentally, the EC2 itself is called the “Expert Committee to review the findings of Large Scale Trials and other related biosafety studies on Bt Brinjal””¦
4. Dr Ananda Kumar, Project Director, NRCPB, Indian Agricultural Research Institute (IARI), Delhi
Dr Ananda Kumar is a Bt Brinjal developer himself. Given that his own product is in the pipeline of development and commercialization, his inclusion in the Expert Committee once again violates principles of fair inquiry and brings in conflicting interests.
Amongst the 16 members of the Committee, both the above (Dr Mathura Rai and Dr Ananda Kumar) are agriculture scientists and both are involved in Bt Brinjal development and were made part of this Expert Committee!
In the above context, it may be noted that the Expert Committee has denied that India is a Centre of Origin of Brinjal, even though the crop developer also accepts this fact along with other agencies like National Bureau of Plant Genetic Resources!
5. Dr Dilip Kumar, Director, Central Institute of Fisheries Education, Mumbai
The Central Institute of Fisheries Education had taken up a Mahyco-sponsored study on Bt Brinjal and the Director was now sitting in the Expert Committee to review his Institute’s findings amongst other findings!
6. & 7. Dr Vasantha Muthuswamy and Dr B Sesikeran, Director, National Institute of Nutrition
These two members played a lead role in the recasting of regulatory guidelines for safety assessment of GM foods in India, with the funding of USAID under the South Asia Biosafety Programme (SABP). Dr Muthuswamy is a GEAC member while Dr Sesikeran is an RCGM member.
On the grounds of harmonizing the Indian regulatory regime with Codex Alimentarius guidelines, this exercise not only ignored all the many important tests and procedures being prescribed by Dr Pushpa Bhargava, the Supreme Court observer in the GEAC and others, but threw out many tests that were hitherto being conducted in India.
Incidentally, the ABSPII, (funded by USAID) “works collaboratively with the Program for Biosafety Systems (PBS) and the South Asia Biosafety Program (SABP)1” (funded by USAID). The official website states the following in this context:
“ABSPII will identify and support other USAID initiatives to promote safe and effective agricultural biotechnology in Africa and Asia. For example, successful commercialization of bio-engineered crops will depend upon satisfactory biosafety regulation”.
USAID, meanwhile, states that one of its roles is to “integrate GM into local food systems”2.
Also interesting to note is a KIA Board Meeting (5th Board Meeting of Indo-US Knowledge Initiative on Agriculture, the bilateral deal signed along with the Indo-US nuclear deal, to bring in the so-called second green revolution into the country) expressly refers to the fact that “guidelines are being drafted for the safety of GM foods for the Government of India” under a section titled “related activities undertaken by other US agencies”.
Dr Muthuswamy and Dr Sesikeran were key members of the drafting committee for the new guidelines. It is of little surprise then that the EC2 report repeatedly resorts to comments like “as per the recently adopted guidelines, such studies do not form part of safety assessment” or that something is “not required” as per the new guidelines.
Thus, with USAID’s interference through the SABP project, unscientific safety testing guidelines and processes have become the criteria for the safety assessment of Bt Brinjal and GM crops rather than rigorous scientific risk assessment and hazard identification. Further, a scientific evaluation of Bt Brinjal is not about conformity to guidelines (newly adopted or otherwise) even
as the EC2 report takes a recourse to this often.
8. & 9. Dr Dhir Singh and Dr S B Dongre, “representatives of the Ministry of Health & Family Welfare”
These two members of the EC2, drawn from the Food Safety and Standards Authority, were expressly designated in the EC2 as “representatives of the Ministry of Health & Family Welfare”.
From conversations with the FSSA Chairperson and one of these members, it is gleaned by civil society members that these members carried a brief of being present in the EC2 as “observers” and did not take part in the deliberations.
In effect, this implies that no health-related questions were being asked on behalf of the public by any Health Ministry representative in the Expert Committee!
10. Dr C M Gupta, Former Director, Central Drug Research Institute, Lucknow
Dr Gupta, who is also a GEAC member, did not attend both the meetings of EC2.
11. Dr Ranjini Warrier, Member-Secretary, GEAC & Convenor, EC2
It is to Dr Warrier that various communications were sent by many civil society groups about the constitution and mandate of the Expert Committee, right from February 2009. It is obvious that no notice was paid to the objectionable processes being run and that justified demands from citizens were not taken on board.
2 USAID Announces International Biotech Collaboration. US Department of State, June 2002
EXPERT COMMITTEE & SUBSEQUENT PROCESSES
The Expert Committee met twice, on July 30th and August 31st 2009 reportedly for a few hours each, and came up with its 105-page report. In these two meetings, thousands of pages of biosafety dossiers of Bt Brinjal in addition to independent reviews and other feedback were apparently perused by the Committee for finalizing its report!
The GEAC did not address the issues raised by civil society groups about the constitution and mandate of this Expert Committee.
Further, information on attendance in the two meetings of the EC2 (Annexure 5) shows the following:
12 out of 16 members attended the first meeting; 11 out of 16 members attended the second meeting.
Dr Lalitha Gowda of CFTRI and Dr C M Gupta did not attend both the EC2 meetings.
Dr Dharmeshwar Das of IVRI, Dr A K Shrivastava of NDRI and Dr K Satyanarayana of ICMR attended only the first meeting. Dr Satyanarayana is incidentally part of the RCGM, the GEAC as well as the EC2!
Dr S B Dongre and Dr Dhir Singh of the MoH&FW attended only the second meeting.
Civil society members’ interactions with a few of the EC2 members reveals that at least two of them were not even aware that the EC2 report was finalized and was going to be discussed on October 14th, when met on October 12th!
The GEAC meeting which cleared Bt Brinjal seemed to have functioned with just about half of its members being present for the meeting (this appears to be the case from the Minutes of this meeting, though the minutes do not record the names of all the people present); the clearance also came amidst some dissent and a few concerns expressed.
IS THIS WHAT WE SHOULD BE TRUSTING, THEN?
It is very clear from the documents related to ABSPII and SABP projects and the actual happenings in the Indian regulatory regime that American interests are driving the decision-making processes in India; it will also not be an exaggeration to say that it is American corporate interests, seeking markets and acceptability for GM seeds, that are driving the agenda here and Indians are being made into lab rats in this irresponsible, irreversible and completely unneeded experiment!
To suit a pre-decided agenda, the processes are being rigged up to come up with a particular, predictable and dangerous outcome and this is being thrust on the country by the highest authorities in India.
The Expert Committee which recommended Bt Brinjal for India is clearly:
* unethical in its functioning (the Chair buckling under pressure, one member against whom a CVC complaint is pending for excessive favouring of Mahyco in an Expert Committee considering Mahyco’s product, members not being aware of the report being ready, a very short time taken to prepare the report making some experts wonder if this was a pre-written report by the crop developer”¦.);
* designed for recommending Bt Brinjal (given its constitution, functioning, mandate and attendance);
* unscientific (as initial comments from some experts already indicate but as reflected in responses like “this is not required as per the newly adopted guidelines” etc.).
Detailed responses from all over the country in the coming days will certainly showcase the details and extent to which the EC2 has been unscientific.
Further, GEAC was undemocratic in not taking on board genuine issues and concerns with the constitution and mandate of the Expert Committee. To this day, for instance, there is no convincing answer on why we need Bt Brinjal in this country!
It is based on this Expert Committee’s recommendations that the GEAC cleared Bt Brinjal for commercial cultivation in India and right now, the Minister for Environment & Forests, Government of India, is seeking public feedback on this very Expert Committee’s report.
Is this fair and trustworthy? Do you want to rest your faith with regard to your health, environment and that of your future generations in the hands of these Committees?
If NOT, write to the Prime Minister and the Minister for Environment & Forests, asking them to withdraw the Expert Committee report immediately.
1. Mr. Jairam Ramesh,
Hon’ble Minister of State (Independent charge)
Ministry of Environment & Forests (MOEF)
CGO Complex, Lodhi Road
New Delhi - 110003, India
2. Dr Manmohan Singh,
Hon’ble Prime Minister of India,
# 7, Race Course Road,
New Delhi 110001.
Fax: 011-23015603, 011-23019545,
You may also submit your comments/observations to Minister for Environment & Forests,
via MoEF website: http://moef.nic.in/modules/contact-ministry/contact-ministry/